Winco Original Formula Eye Drops (Tetrahydrozoline Hcl) Liquid [Winco Foods, Llc] -

WINCO ORIGINAL FORMULA EYE DROPS (TETRAHYDROZOLINE HCL) LIQUID [WINCO FOODS, LLC]
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Active ingredient

Tetrahydrozoline HCL 0.05%
Purpose

Redness reliever
Uses
- relieves redness of the eye due to minor eye irritations
Warnings
For external use only

Ask a doctor before use if you have

narrow angle glaucoma
When using this product
- pupils may become enlarged temporarily
- to avoid contamination, do not touch tip of container to any surface. Replace cap after using
- if solution changes color or becomes cloudy, do not use
- overuse may produce increased redness of the eye
- remove contact lens before using
Stop use and ask a doctor if

you experience
- eye pain
- changes in vision
- continued redness or irritation of the eye, or if the condition worsens or persists for more than 72 hours
If pregnant or breast-feeding

ask a health professional before use

Keep out of reach of chlidren

If swallowed, get medical help or contact a Poison Control Center (1-800-222-1222) right away.
Directions

Instill 1 or 2 drops in the affected eye(s) up to four times daily
Other information

store at 15-30°C (59°-86°F)
Inactive ingredients

benzalkonium chloride, boric acid, edetate disodium, purified water, sodium borate, sodium chloride
PDP
Carton

INGREDIENTS AND APPEARANCE

WINCO ORIGINAL FORMULA EYE DROPS
tetrahydrozoline hcl liquid

Ingredient Name	Basis of Strength	Strength
Active Ingredient/Active Moiety
TETRAHYDROZOLINE HYDROCHLORIDE (UNII: 0YZT43HS7D) (TETRAHYDROZOLINE - UNII:S9U025Y077)	TETRAHYDROZOLINE HYDROCHLORIDE	0.05 g in 100 mL

Ingredient Name	Strength
Inactive Ingredients
BENZALKONIUM CHLORIDE (UNII: F5UM2KM3W7)
BORIC ACID (UNII: R57ZHV85D4)
EDETATE DISODIUM (UNII: 7FLD91C86K)
WATER (UNII: 059QF0KO0R)
SODIUM BORATE (UNII: 91MBZ8H3QO)
SODIUM CHLORIDE (UNII: 451W47IQ8X)

#	Item Code	Package Description	Marketing Start Date
Packaging
1	NDC:67091-310-15	1 in 1 CARTON	09/26/2018
1		15 mL in 1 BOTTLE, PLASTIC; Type 0: Not a Combination Product

Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
Marketing Information
OTC monograph final	part349	09/26/2018

Labeler - WinCo Foods, LLC (056098817)

Registrant - KC Pharmaceuticals, Inc. (174450460)

Name	Address	ID/FEI	Business Operations
Establishment
KC Pharmaceuticals, Inc.		174450460	manufacture(67091-310) , pack(67091-310) , label(67091-310)

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